Compreensão do termo de consentimento informado

• Autor(a) principal: Biondo-simões, Maria De Lourdes Pessole [UNIFESP]
• Data de Publicação: 2007
• Outros Autores: Martynetz, Juliano, Ueda, Fernanda Matie Kinoshita, Olandoski, Márcia
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Repositório Institucional da UNIFESP
• Texto Completo: http://dx.doi.org/10.1590/S0100-69912007000300009; http://repositorio.unifesp.br/handle/11600/3709
• topic: Informed consent; Consent forms; Consentimento esclarecido; Termos de consentimento

BACKGROUND: Informed consent is compulsory in professional practice and research studies involving human beings. It represents respect to autonomy. This study aims at identifying the degree of understanding displayed by individuals who participate in research studies or treatment. METHODS: An informed concent form was prepared and written in a clear and comprehensible language, with a Flesch Reading Ease Score of 95, and thus classified as very easy. Age, schooling, readership frequency, access to information and to the Internet, and family income were analyzed as factors bearing on comprehension of free and informed consent. RESULTS: Even though the form was prepared to result in a comprehension score of 9 and 10, the score observed was 7.5 ± 1.62 and was not related to age or gender. Schooling level was seen to affect comprehension (p=0.0013) as well as readership frequency (p=0.0001) and access to the Internet (p=0.0070). The income level analysis revealed that individuals who earn more than 10 times the minimum wage showed better comprehension (p=0.0041). CONCLUSION: It can be concluded that individuals participating in research studies should be chosen among those with better schooling, frequent readership, easy access to the Internet, and within a higher income bracket. In medical practice, each patient's condition should be observed, their comprehension limitations understood, and the informed consent form should be read on a one-to-one basis, and all the details and implications should be clearly explained.